Mifortic

Package Leaflet: Information for the User

Myfortic 180 mg Gastro-Resistant Tablets

mycophenolic acid (as mycophenolate sodium)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What Myfortic is and what it is used for
• 2. What you need to know before you take Myfortic
• 3. How to take Myfortic
• 4. Possible side effects
• 5. How to store Myfortic
• 6. Contents of the pack and other information

1. What Myfortic is and what it is used for

Myfortic contains the active substance mycophenolic acid. It belongs to a group of medicines called immunosuppressants.
Myfortic is used to prevent the body from rejecting a transplanted kidney, by reducing the activity of the immune system. It is used in combination with cyclosporin and corticosteroids.

2. What you need to know before you take Myfortic

WARNING
Mycophenolate causes birth defects and miscarriage. Women who may become pregnant must have a negative pregnancy test before starting treatment and must use contraception as advised by their doctor.
Your doctor will discuss with you and give you written information about the risks of mycophenolate to the unborn baby. You should read this information carefully and follow the advice given. If you have any questions or concerns, you should talk to your doctor before taking mycophenolate. See also section “Pregnancy and breast-feeding”.

When not to take Myfortic

• if you are allergic to mycophenolic acid, mycophenolate sodium, mycophenolate mofetil or to any of the other ingredients of this medicine (listed in section 6);
• if you are a woman who could become pregnant and have not had a negative pregnancy test before your first dose of Myfortic, because mycophenolate causes birth defects and miscarriage;
• if you are pregnant or planning to become pregnant or think you may be pregnant;
• if you are not using effective contraception (see section “Contraception in women taking Myfortic”);
• if you are breast-feeding (see also section “Pregnancy and breast-feeding”).

If any of the above applies to you, tell your doctor before taking Myfortic.

Special warnings and precautions

Before you start taking Myfortic, tell your doctor if:

• you have or have had any severe gastrointestinal disorders, such as stomach ulcers;
• you have a rare inherited deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase (HGPRT), such as Lesch-Nyhan or Kelley-Seegmiller syndrome.

Things to be aware of:

• Myfortic reduces your body’s defence mechanism, which makes you more susceptible to infections. You should try to avoid contact with people who have infections and report any signs of infection to your doctor immediately.
• Myfortic may increase the risk of developing certain types of cancer, including skin cancer. You should limit your exposure to sunlight and UV light by wearing protective clothing and using a sunscreen with a high protection factor.
• if you have had a previous infection of the brain, such as progressive multifocal leukoencephalopathy (PML), your doctor may need to monitor you for any signs of this infection returning.
• if you have previously had hepatitis B or C, Myfortic may increase the risk of these conditions coming back. Your doctor may need to monitor you for signs of these conditions.
• if you have persistent coughing or difficulty breathing, especially if you are taking other immunosuppressive medicines, you should tell your doctor immediately.
• your doctor may need to monitor your blood count and advise you to stop taking Myfortic if your blood count falls below a certain threshold.
• if you experience any symptoms of infection, such as fever or sore throat, or unexplained bruising or bleeding, you should tell your doctor immediately.
• the active substance in Myfortic, mycophenolic acid, is not the same as other medicines with similar-sounding names, such as mycophenolate mofetil. Do not take them interchangeably without talking to your doctor.
• taking Myfortic during pregnancy may harm your unborn baby and increase the risk of miscarriage.

Children and adolescents

Due to a lack of data, Myfortic is not recommended for use in children and adolescents.

Elderly patients

In elderly patients (65 years or older), Myfortic can be used at the same dose as for younger patients.

Myfortic and other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.
In particular, tell your doctor if you are taking any of the following:

• other immunosuppressive medicines, such as azathioprine or tacrolimus;
• medicines used to treat high cholesterol, such as cholestyramine;
• activated charcoal, used to treat gastrointestinal disorders, such as diarrhoea, stomach upset and gas;
• antacids, which contain magnesium and aluminium;
• medicines used to treat viral infections, such as acyclovir or ganciclovir.

Also, tell your doctor if you are planning to receive any vaccinations.
Patient with Myfortic should not donate blood during and for at least 6 weeks after stopping treatment.
Men with Myfortic should not donate semen during and for at least 90 days after stopping treatment.

Taking Myfortic with food and drink

Myfortic can be taken with or without food. You should decide which is best for you and take it the same way each day to ensure it is absorbed at the same rate.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will discuss with you the risks and benefits of taking Myfortic during pregnancy or breast-feeding.

• if you are planning to become pregnant;
• if you have missed a period or think you may be pregnant or have unusual menstrual bleeding;
• if you have had unprotected sex. If you become pregnant while taking Myfortic, you must immediately tell your doctor. However, you should continue to take Myfortic until you have spoken to your doctor.

Pregnancy
Mycophenolate can cause severe birth defects and miscarriage.
Women of childbearing potential must use effective contraception and have a negative pregnancy test before starting treatment with Myfortic.

Contraception in women taking Myfortic

Women who can become pregnant must use effective contraception during treatment with Myfortic and for 6 weeks after stopping treatment.
Women should discuss with their doctor the most suitable method of contraception for them.

• before starting treatment with Myfortic;
• during treatment with Myfortic;
• for 6 weeks after stopping treatment with Myfortic. You should talk to your doctor about the most suitable method of contraception for you. The choice will depend on your individual situation. It is recommended that you use two methods of contraception at the same time to prevent pregnancy.

A woman is considered unable to become pregnant if she:

• is post-menopausal, i.e. at least 50 years old and her periods have stopped for at least a year (if her periods have stopped due to treatment of cancer, she may still be fertile);
• has had both ovaries removed;
• has had her womb removed;
• her ovaries do not work (premature ovarian failure, which has been confirmed by a gynaecologist);
• was born with one of the following rare conditions, which make it impossible to become pregnant: XY genotype, Turner syndrome or uterine agenesis;
• is a child or adolescent who has not yet started their periods.

Contraception in men taking Myfortic

Available data do not indicate an increased risk of miscarriage or birth defects in babies whose fathers are taking mycophenolate.
However, as a precautionary measure, it is recommended that men taking Myfortic use condoms during treatment and for 90 days after stopping treatment.

Driving and using machines

Myfortic has a minor influence on the ability to drive and use machines.

Myfortic contains sodium

This medicine contains 13 mg of sodium per 180 mg tablet, which is essentially ‘sodium-free’.

Myfortic contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Myfortic

Always take Myfortic exactly as your doctor has told you. Myfortic should only be prescribed by doctors who have experience in treating patients with transplanted organs.
If you are not sure, ask your doctor or pharmacist.

How much to take

The recommended daily dose of Myfortic is 1440 mg (8 tablets of 180 mg), taken as two separate doses of 720 mg (4 tablets of 180 mg) each.
Take the tablets in the morning and evening.

In patients with severe kidney problems

The daily dose should not be more than 1440 mg (8 tablets of 180 mg).

How to take Myfortic

Swallow the tablets whole with a glass of water.
Do not break or crush the tablets.
Do not take tablets that have been broken or crushed.

If you take more Myfortic than you should

If you have taken more tablets than you should, contact your doctor or go to the nearest hospital immediately. You may need medical attention. Take the medicine pack with you.

If you forget to take Myfortic

If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Then continue as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Myfortic

Do not stop taking Myfortic unless your doctor tells you to. Stopping Myfortic may increase the risk of rejection of your transplanted kidney.

4. Possible side effects

Like all medicines, Myfortic can cause side effects, although not everybody gets them.
Older patients may experience more side effects due to a weaker immune system.
Immunosuppressive medicines, including Myfortic, reduce the body’s defence mechanism, which can increase the risk of infections and cancer.

Side effects which may be serious:

• symptoms of infection, such as fever, chills, excessive sweating, feeling tired, sleepiness, or lack of energy;
• vomiting blood, black or bloody stools, stomach or intestinal ulcers;
• enlarged lymph nodes, new lumps or changes in existing lumps on the skin;

Other side effects:

Very common(may affect more than 1 in 10 people)

• low white blood cell count
• low calcium levels in the blood
• low potassium levels in the blood
• high levels of uric acid in the blood
• high blood pressure
• anxiety
• diarrhoea
• joint pain

Common(may affect up to 1 in 10 people)

• low red blood cell count, which may cause tiredness, shortness of breath and pale skin
• low platelet count, which may cause bruising or bleeding
• high potassium levels in the blood
• low magnesium levels in the blood
• dizziness
• headache
• cough
• low blood pressure
• shortness of breath
• stomach or intestinal problems, such as abdominal pain, gastritis, bloating, constipation, indigestion, wind, loose stools, nausea, vomiting
• feeling tired, fever
• abnormal liver or kidney function tests
• respiratory tract infections
• acne
• weakness
• muscle pain
• swelling of hands, ankles or feet
• itching

Uncommon(may affect up to 1 in 100 people)

• fast heart rate or irregular heartbeat, fluid in the lungs
• growth of cysts containing fluid (lymphocele)
• trembling, difficulty sleeping
• redness and swelling of the eyes, blurred vision
• snoring
• belching, bad breath, bowel obstruction, mouth ulcers, tooth discolouration, dry mouth, gum inflammation, pancreatitis
• blood infections, skin and soft tissue infections
• blood in the urine, kidney damage, pain or difficulty urinating
• hair loss, skin discoloration
• joint inflammation, back pain, muscle cramps
• loss of appetite, high levels of lipids, sugar, cholesterol or low levels of phosphate in the blood
• flu-like symptoms, swelling of the hands and feet, pain, stiffness or weakness of the muscles
• abnormal dreams, hallucinations
• impotence
• cough, difficulty breathing, pain when breathing

Frequency not known(cannot be estimated from the available data)

• fever, sore throat, frequent infections (possible signs of a low white blood cell count)
• rash, itching, hives, difficulty breathing or swallowing, wheezing or coughing, feeling faint or dizzy, changes in blood pressure, flushing of the skin, swelling of the face, lips, tongue or throat (severe allergic reactions)

Other side effects reported with medicines like Myfortic

Additionally, the following side effects have been reported with medicines like Myfortic: colon inflammation, cytomegalovirus gastritis, perforation of the gastrointestinal tract, stomach or duodenal ulcers, low white blood cell count or low platelet count, severe infections, such as endocarditis or meningitis, shortness of breath, cough (which may be caused by bronchiectasis), and other less common bacterial infections which can cause severe lung disease.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system listed in the “Further information” section.

5. How to store Myfortic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture.

6. Contents of the pack and other information

What Myfortic contains

• The active substance is mycophenolic acid (as mycophenolate sodium). Each tablet contains 180 mg of mycophenolic acid.
• The other ingredients are:
• tablet core: maize starch, povidone, crospovidone, lactose, colloidal anhydrous silica, magnesium stearate.
• tablet coating: hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132).

What Myfortic looks like and contents of the pack

Myfortic 180 mg gastro-resistant tablets are yellow-green, film-coated and round, with “C” marked on one side.
Myfortic 180 mg gastro-resistant tablets are available in packs of 20, 50, 100, 120 or 250 tablets in blisters.

Marketing Authorisation Holder

Novartis Poland Sp. z o.o.
Marynarska 15
02-674 Warsaw
Tel. + 48 22 375 48 88

Manufacturer

Lek d.d.
PE PROIZVODNJA LENDAVA
Trimlini 2D, Lendava, 9220
Slovenia
Novartis Poland Sp. z o.o.
Marynarska 15
02-674 Warsaw
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nürnberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nürnberg
Germany
Novartis Pharma GmbH
Jakov-Lind-Straße 5, Top 3.05
1020 Wien
Austria
Novartis Pharmaceutical Manufacturing LLC
Verovskova Ulica 57
Ljubljana, 1000
Slovenia
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Myfortic: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain.

Date of last revision of the leaflet:

10/2024

Further information

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.